JP6895014B2 - Stool sample testing device, stool sample testing method - Google Patents

Description

The present invention relates to a technique for testing a stool sample.

Feces, which is one of the biological samples, is one of the important samples from which information in the digestive tract can be obtained. The stool is mostly water, with the rest being dead intestinal parietal cells, dead intestinal bacteria, and food residues. The stool provides useful information about digestive disorders and is useful in diagnosing the disorders.

Colorectal cancer, which has been on the rise in recent years, may have a small amount of blood adhering to the surface of the stool as it passes through the large intestine in the early stages without subjective symptoms. This small amount of blood is called fecal occult blood because it cannot be seen with the naked eye. The fecal occult blood test attempts to detect colorectal polyps and early-stage colorectal cancer by detecting fecal occult blood. It can be performed at a relatively low cost and the burden on the test is small. It is widespread.

As a method for detecting fecal occult blood, there are the guaiac method and the orthotridine method using biochemical reactions in the old days, but they are rarely practiced at present due to their low specificity. Instead, the mainstream is the detection of fecal occult blood markers by immunological methods. Hemoglobin is a typical marker for fecal occult blood, but blood-derived substances such as calprotectin, transferrin, and hemoglobin-haptoglobin complex are also used as markers for fecal occult blood.

Since the fecal occult blood test detects the presence or absence of bleeding in the gastrointestinal tract, it is not necessarily specific to colorectal cancer. Therefore, the search for colorectal cancer markers present in stool is continuing. For example, Patent Document 1 reports a biomarker for colorectal cancer based on the results of mass spectrometry of stool samples. Further, Patent Document 2 reports methylation of a gene peculiar to cancer cells contained in feces.

An example of the flow of the fecal occult blood test is shown below.
1) The subject of the fecal occult blood test collects a stool sample at home using a dedicated stool collection container.
2) Submit the stool collection container containing the collected stool sample to the inspection institution.
3) At the inspection institution, the inspector sets the stool collection container in the inspection device and carries out a fecal occult blood test (inspection by the method is also possible).

If the fecal occult blood test is positive, the presence of colorectal polyps or colorectal cancer is suspected, so a detailed test such as colonoscopy is performed.

Since the stool sample is in the form of a paste, it is difficult to collect a certain amount of the stool sample as compared with a liquid biological sample such as blood or urine. Reagent manufacturers that sell fecal occult blood test reagents are developing stool collection containers that can always collect a certain amount of stool samples, but the problem of excess or deficiency of sample volume is always present.

In addition, stool samples are often collected by the subject at home, and the amount collected often varies depending on the procedure of the subject. Occasionally, due to the subject's misunderstanding or immature procedure, a stool sample may be significantly insufficient, or an uncollected stool collection container for which a stool sample has not been collected may be submitted to the laboratory.

Even in the state of uncollected stool for which a stool sample has not been collected, it is difficult to visually detect it from the outside of the stool collection container. This is because the amount of stool required for the fecal occult blood test is very small, and the collected stool sample is suspended in the stool collection buffer in the stool collection container and dispersed. However, the presence or absence of a stool sample cannot be visually determined from the outside of the stool collection container. If a fecal occult blood test is performed in a state where stool has not been collected, the test result will always be negative for fecal occult blood, so there is a risk of overlooking colorectal polyps and colorectal cancer.

Patent Document 3 discloses a method for correcting stool volume by measuring the absorbance of a resident substance or stool suspension present in stool when measuring hemog mouth bottle and / or transferrin, which are markers of fecal occult blood. There is. However, although Patent Document 3 can accurately measure the fecal occult blood marker concentration, a method for distinguishing whether the fecal occult blood marker is not detected or the stool is not collected when a fecal occult blood negative result is obtained. Is not disclosed.

International Publication No. 2013/162368 International Publication No. 2017/043497 International Publication No. 2001/061343

An object of the present invention is to improve the accuracy of a stool sample test by detecting an uncollected stool sample in the stool sample test, thereby suppressing oversight of detection of a substance to be measured contained in the stool sample.

The present inventors have made diligent studies to solve the above problems, and have completed the following inventions.
(1) A sample inhalation unit, a stool collection confirmation unit that detects uncollected stool samples based on the absorbance of the sample measured at the first wavelength, and a sample inspection unit are provided.
A stool sample testing device that includes a stool suspension solution containing a buffer solution and may further contain a stool sample.
(2) The uncollected stool sample is a sample showing an absorbance below a preset threshold value.
The stool sample testing device according to (1), wherein the threshold value is determined based on the absorbance of the stool suspension solution.
(3) The stool sample inspection device according to (1) or (2), wherein the inspection unit for the sample has an absorbance measurement unit for a second wavelength.
(4) The stool sample inspection apparatus according to any one of (1) to (3), wherein the first wavelength is in the range of 300 nm to 510 nm.
(5) The stool sample inspection apparatus according to any one of (1) to (3), wherein the first wavelength is in the range of 300 nm to 450 nm.
(6) The first wavelength is any one of 295 nm to 305 nm, 335 nm to 345 nm, 375 nm to 385 nm, 400 nm to 415 nm, 445 nm to 455 nm, and 480 nm to 505 nm (1) to (1). The stool sample inspection device according to any one of 3).
(7) The stool sample inspection apparatus according to any one of (1) to (6), wherein the inspection unit for the sample is an examination unit for carrying out an immunological measurement method.
(8) The stool sample inspection apparatus according to (7), wherein the immunological measurement method is performed by an agglutination measurement method using insoluble carrier particles.
(9) The stool sample testing apparatus according to any one of (1) to (8), wherein the testing unit of the sample detects a fecal occult blood marker and / or a tumor marker in the stool suspension. ..
(10) Any of (3) to (9), wherein the stool collection confirmation unit that performs the absorbance measurement at the first wavelength also serves as the absorbance measurement unit at the second wavelength. The stool sample inspection device described in Crab.

(11) This is a stool sample test method.
The process of measuring the absorbance of the sample at the first wavelength,
A stool collection confirmation step for detecting an uncollected stool sample based on the measured absorbance, and a stool collection confirmation step.
It has a sample inspection process to measure the components in the sample.
A method for inspecting a stool sample, wherein the sample contains a solution for suspending stool containing a buffer solution and may further contain a stool sample.
(12) The uncollected stool sample is a sample showing an absorbance below a predetermined threshold value.
The stool sample test method according to (11), wherein the threshold value is determined based on the absorbance of the stool suspension solution.
(13) The stool sample inspection method according to (11) or (12), wherein the first wavelength is in the range of 300 nm to 510 nm.
(14) The stool sample inspection method according to (11) or (12), wherein the first wavelength is in the range of 300 nm to 450 nm.
(15) The first wavelength is any one of 295 nm to 305 nm, 335 nm to 345 nm, 375 nm to 385 nm, 400 nm to 415 nm, 445 nm to 455 nm, and 480 nm to 505 nm. The stool sample inspection method according to 12).
(16) The stool sample inspection method according to any one of (11) to (15), wherein the inspection step of the sample is an absorbance measurement at a second wavelength different from the first wavelength. ..
(17) The stool sample test method according to any one of (11) to (16), wherein the test of the sample is carried out by an immunological measurement method.
(18) The stool sample test method according to (17), wherein the immunological measurement method is performed by an agglutination measurement method using insoluble carrier particles.
(19) The stool test method according to any one of (11) to (18), wherein the test step of the sample detects a fecal occult blood marker and / or a tumor marker in the sample.
This specification includes the disclosure content of Japanese Patent Application No. 2018-085688, which is the basis of the priority of the present application.

According to the present invention, by detecting an uncollected stool sample in a stool sample test, it is possible to suppress overlooking of detection of a substance to be measured contained in the stool sample and improve the accuracy of the stool sample test.

FIG. 1 is a diagram showing a schematic configuration example of an analysis mechanism by a squeeze-up method. It is a functional block diagram which shows one configuration example of the fecal occult blood test apparatus which has the stool collection confirmation mechanism by this embodiment. FIG. 5 is a flowchart showing an example of a flow of a fecal occult blood test process using a fecal occult blood test device having a stool collection confirmation mechanism shown in FIG. It is a sequence diagram which shows an example which arranged the process corresponding to FIG. 3 in time series. It is a figure which shows an example of the absorbance spectrum of a stool suspension.

The stool sample inspection device according to the embodiment of the present invention will be described in detail below with reference to the drawings. The stool sample inspection device according to the present embodiment is characterized by including a stool collection confirmation mechanism for detecting an uncollected stool sample.

The sample tested in the present invention contains a stool suspension solution containing a buffer solution, and preferably further contains a stool sample.

The stool sample inspection device of the present invention is useful for detecting an uncollected stool sample in which the stool sample is substantially not contained in the sample. The term "uncollected stool" in the present invention means that stool is not substantially contained in the stool collection container. "Substantially free of stool" in the sample means stool with an absorbance of less than or equal to the sample amount, which indicates below the threshold value set for determining whether or not stool has not been collected, as will be described later. It means that it contains or does not contain any stool sample. The cause of "uncollected stool" is that the stool sample was intended to be collected due to the lack of procedure of the subject, but the stool sample could not be collected, or only a very small amount of stool sample could be collected. Furthermore, it is possible that he accidentally submitted a stool collection container that does not contain a stool sample without collecting stool.

(Overall composition)
The stool sample inspection device of the present invention is composed of a sample inhalation unit, a stool collection confirmation unit, and a sample inspection unit. Further, according to one embodiment of the present invention, the stool sample inspection device includes a control unit. When handling a larger number of samples, a transport unit for transporting a stool collection container or a sample rack containing the stool collection container may be included.
FIG. 2 is a functional block diagram showing a configuration example of a stool collection confirmation system A including a stool sample inspection device. The stool collection confirmation system A includes an input device 1-1, a control unit 1-2, an output device 1-3, a sample inhalation unit 1-4, a stool collection confirmation unit 1-5, and a fecal occult blood test unit 1. It has -6 and. Specific examples of each functional unit are shown in FIG.
In FIG. 2, the arrow indicates the flow of the input / output signal, and the white arrow indicates the flow of the stool suspension.

(Sample suction part)
The sample inhalation unit 1-4 collects a sample from the stool collection container and sends the liquid to the stool collection confirmation unit 1-5. Taking the case where the sample contains a stool sample as an example, the procedure for collecting the sample is shown in the left figure of FIG. 1 and the right figure of FIG. The stool collection container 21 has a container main body 3, a sample cup 22, and a container lid 5 provided so as to fit into the container main body 3. The container lid 5 has a sampling rod 7 for collecting a stool sample. The container body 3 stores a stool suspension solution containing a buffer solution inside. The stool sample container 21 containing the stool sample collected by the subject with the sampling rod 7 and the stool suspension solution (hereinafter referred to as “stool suspension” 15) is inspected with the sample cup portion 22 facing up. It is set in the sample suction part of the device.
By pressing the side surface of the stool collection container 21 with the pressing portion 26, the liquid level of the stool suspension in the stool collection container is pushed up, and the sample is filtered from the inside of the stool collection container main body 3 through the filter portion 23. The stool suspension is stored in the cup portion 22 (squeeze-up method). The sample nozzle 24 of the sample suction section is inserted into the sample cup section 22, and the stool suspension stored in the sample cup section 22 is sucked by the sample nozzle 24. Further, the inhaled stool suspension is sent to the stool collection confirmation section and the sample inspection section for measurement. Reference numeral 25 is a gripping portion capable of gripping the stool collection container main body portion 3. The sample is carried out in the same manner even in the case of an uncollected stool sample.

(Stool collection confirmation department)
The stool collection confirmation unit 1-5 measures the absorbance of the sample inhaled by the sample inhalation unit 1-4. The measured value of absorbance is sent to the control unit 1-2. The stool collection confirmation unit 1-5 determines whether or not the stool sample is substantially present in the sample, that is, whether or not the stool has not been collected. Since the stool suspension is inspected by measuring the absorbance, it is preferable to integrate the stool collection confirmation unit 1-5 and the stool occult blood examination unit 1-6.
As an index for confirming stool collection, the concentration of resident substances in stool such as inorganic phosphorus, calcium, magnesium, alkaline phosphatase, and amylase, or the absorbance of the sample can be mentioned. Of these, the absorbance measurement of the stool suspension does not require a reagent or reaction for confirming stool collection, and the stool suspension after the absorbance measurement can be used as it is as a sample for the subsequent stool sample test, which is preferable.

(Absorbance measurement)
The wavelength of the absorbance measurement in confirming stool collection is not particularly limited as long as it is in the region of 300 nm to 510 nm, but a region of 300 nm to 450 nm, in which the difference in absorbance between the stool suspension solution and the stool suspension is large, is more preferable. Further, the measurement wavelength for confirming stool collection is preferably selected from 300 nm, 340 nm, 400 nm to 415 nm, 445 nm to 455 nm, and 480 nm to 505 nm. As a result, the optical system of a general-purpose biochemical measuring device can be diverted, and the cost of the device can be reduced.

FIG. 5 is a diagram showing the absorbances of a 0.5% stool suspension and a stool suspension solution of 31 normal stool samples, with the horizontal axis representing the measurement wavelength and the vertical axis representing the absorbance. In FIG. 5, the alternate long and short dash line is the absorbance (average +2.6 SD) of the stool suspension solution, the dotted line is the absorbance (median value) of 31 stool suspension samples, and the broken line is the stool suspension 31. It shows the absorbance (minimum value) of the sample. The solid line plots the difference between the absorbance of the stool suspension solution and the absorbance (minimum value) of the 0.5% stool suspension.

The alternate long and short dash line plot is the average value of the absorbances of multiple lots + 2.6 S. D. Therefore, the absorbance of the stool suspension solution is virtually never higher than the alternate long and short dash plot (statistical probability is 0.5%). Further, looking at the solid line plot, it can be seen that there is a sufficient difference between the absorbance of the stool suspension solution and the absorbance (minimum value) of the stool suspension in the region of 300 nm to 510 nm. Therefore, if the threshold value is set based on the absorbance of the stool suspension solution measured in advance, the sample showing the absorbance below the threshold value does not contain any stool sample, or only a very small amount of stool sample can be collected. That is, it can be detected as a sample of "uncollected stool" in the present invention.

It is preferable to use a disposable plastic cell as the measuring container used for the absorbance measurement from the viewpoint of contamination prevention and cost. The transmission wavelength of the polystyrene cell is in the range of 320 nm to 800 nm, and the transmission wavelength of the polymethyl methacrylate resin is in the range of 285 nm to 800 nm. An appropriate cell may be selected and used according to the above-mentioned measurement wavelength.
If the amount of the sample liquid is insufficient for the absorbance measurement, a buffer solution or the like can be added as long as the measurement is not affected.

(Failure confirmation judgment)
The absorbance measurement result in the stool collection confirmation unit is sent to the control unit to determine the presence or absence of stool collection. If the absorbance of the sample exceeds the threshold value, it is determined that the sample contains a stool sample, and the next stool sample test is performed.

On the other hand, when the absorbance of the sample is equal to or less than the threshold value, it is determined that the stool has not been collected, and at least one of the following treatments is executed.
(1) Sound the alarm.
(2) Temporarily stop the inspection.
(3) Print on the printer that the sample has not been collected.
(4) The display screen indicates that the sample has not been collected.
(5) The fact that the sample has not been collected is transmitted to an external device.

In the case of a fecal occult blood marker test in colorectal cancer screening, a large number of samples are first set in the device, and after that, the area around the device may be unmanned until the end of measurement. It is preferable to carry out at least one of them. In addition, the processes (3) to (5) can be performed sequentially, or data related to uncollected stools can be stored in a storage unit attached to the control unit and output collectively after the measurement is completed. May be good.

(Sample Inspection Department)
The sample inspection department detects substances to be measured contained in stool samples, such as markers for digestive system diseases and pathogens. A typical example is the detection of fecal occult blood markers, which are indicators of colorectal cancer. Other inspection items that can be performed include the following.

(1) Tumor markers such as M2PK, IGFBP2, and EpCAM By immunologically detecting colorectal cancer markers present in stool, the specificity / sensitivity of colorectal cancer detection can be determined together with the test results of fecal occult blood markers. Can be enhanced.
(2) Gene markers such as p53, K-ras, and Twist1 Nucleic acid is extracted from stool suspension and analyzed to detect abnormal expression, mutation, or methylation of genes specifically found in colorectal cancer. Thereby, the specificity / sensitivity of colorectal cancer detection can be enhanced together with the test result of the fecal occult blood marker.
(3) Detection of pathogens causing food poisoning Pathogens Hemorrhagic Escherichia coli and its toxins, Norwalk virus, rotavirus, etc. are detected to identify the cause of food poisoning.
(4) Helicobacter pylori antigen Helicobacter pylori, which increases the risk of chronic gastritis, gastric ulcer, and gastric cancer, is detected to determine the presence or absence of Helicobacter pylori infection.

According to the present invention, by detecting an uncollected stool sample in the stool sample test, it is possible to suppress oversight of the stool sample test and improve the accuracy of the stool sample test. According to one embodiment of the present invention, it is possible to suppress oversight of fecal occult blood and improve the accuracy of the fecal occult blood test.

(Measuring method)
The measurement methods carried out by the sample inspection department can be broadly divided into immunological measurement methods and molecular biological measurement methods.

(Immunological measurement method)
When the substance to be measured is a protein, glycoprotein, polysaccharide or the like, an immunological measurement method is used. The immunological measurement method is a measurement method utilizing a specific binding between an antigen and an antibody, and various measurement methods are known. Typical examples are latex agglutination immunoturbidimetry (LATIA) and enzyme-labeled immunoassay (EIA, ELISA). Immunological measurement methods can be used to detect fecal occult blood markers, tumor markers, and pathogen-derived antigens.

(Molecular biological measurement method)
When the measurement target is a gene or a mutation of a gene, a molecular biological measurement method is used. The molecular biological measurement method utilizes the property that one single-stranded nucleic acid (DNA or RNA) specifically binds to another single-stranded nucleic acid having a complementary base sequence. Utilizing this property, a base sequence (probe) complementary to the measurement target is prepared to detect a gene specifically expressed in cancer cells or a gene peculiar to a pathogen. When detecting a gene mutation, a probe that specifically binds to the mutation site is used. As a method for detecting cancer cell-specific methylation, a method using base substitution by bisulfite treatment and a method using a methylation-specific restriction enzyme are known.
In carrying out the molecular biological measurement method, the gene to be measured can be amplified in advance. As the gene amplification method, known gene amplification methods such as PCR method, SDA method, NASBA method, and LAMP method can be applied. When the measurement target is a bacterium or a virus, it is possible to amplify the gene peculiar to the measurement target and detect it depending on the presence or absence of an augmented by-product.

(Equipment configuration of sample inspection department)
The sample inspection unit includes a reaction vessel for accommodating a sample containing a stool sample, a reagent supply unit for supplying various reagents to the reaction vessel, and a detection unit for detecting a substance to be measured after a reaction with the reagent. The reaction vessel can also serve as a measuring unit. Further, when the substance to be measured is detected by optical measurement, it can be further integrated with the measuring container of the sample amount shortage determination unit. The sample inspection unit may be provided with a stirring mechanism, a temperature control mechanism capable of heating and cooling, and the like, depending on the measurement method.

(Measurement method of fecal occult blood)
A fecal occult blood test for which the present invention is particularly useful is performed as follows.
Fecal occult blood markers to be measured in colorectal cancer screening include hemoglobin, calprotectin, transferrin, hemoglobin-haptoglobin complex and the like. All of these fecal occult blood markers are blood-derived protein components.
The method for measuring the fecal occult blood marker is not particularly limited as long as it is an immunological measurement method, but the latex agglutination immunoturbidimetry method is suitable because it is a measurement method that does not require detection sensitivity or B / F separation. .. In the latex agglutination immunoturbidimetry method, the fecal occult blood marker is detected by measuring the absorbance. Therefore, the reaction container of the sample inspection unit also serves as the absorbance measurement container, and also serves as the absorbance measurement container of the stool test confirmation unit. ..

FIG. 2 is a functional block diagram showing a configuration example of a fecal occult blood test device with a stool collection confirmation mechanism according to the present embodiment. Here, an example in which fecal occult blood is detected by measuring the concentration of hemoglobin is shown, but the detection target is not limited to hemoglobin.

FIG. 3 is a flowchart showing an example of a flow of a fecal occult blood test process using the fecal occult blood test device with a stool collection confirmation mechanism shown in FIG. FIG. 4 is a sequence diagram showing an example in which the processes corresponding to FIG. 3 are arranged in chronological order.

The measurement of the fecal occult blood marker will be described in detail below with reference to FIG.
The stool suspension collected from the sample cup portion of the stool collection container in step S1 is sent to the stool collection confirmation determination unit and the stool occult blood test unit, and is dispensed into the measurement cell. In step S2, the first reagent is dispensed into the measurement cell. In step S3, the sample and the first reagent are stirred to mix. Within, for example, 5 minutes from this timing, in step S4, for example, light having a first wavelength of 340 nm is irradiated to measure the absorbance for determining the amount of sample shortage.

The first reagent increases the amount of the sample for measuring the absorbance, and at the same time, contains a component that neutralizes an inhibitor of the antigen-antibody reaction that may be contained in the sample. The absorbance may be measured at any timing during this neutralization reaction, that is, between the addition of the first reagent and the addition of the second reagent.

The measured value of the absorbance in the stool collection confirmation step is sent to a control unit described later, and it is determined whether or not the sample contains stool. If it is determined that stool is contained, the next step of measuring the fecal occult blood marker is performed. If it is determined that the stool is not included, the next fecal occult blood marker measurement is performed after the information on the uncollected stool is given.

Next, in step S5, the second reagent containing the antibody-sensitized latex particles is dispensed into the measurement cell, and in step S6, stirring is performed to carry out a latex agglutination reaction.

Then, in step S7, the absorbance of the reaction solution is measured at the second wavelength. The second wavelength is, for example, 660 nm. The wavelength at which the aggregation of the reaction solution is measured is not limited to one wavelength. It is also possible to improve the measurement accuracy by measuring the absorbance of the sub-wavelength in addition to the main wavelength at the same time.

Further, the measurement of the latex agglutination reaction may be an endpoint measurement in which the absorbance is measured after a certain reaction time has elapsed, or the absorbance is measured a plurality of times over time immediately after the start of the reaction to calculate the rate of change in the absorbance. It may be a rate assay.

The absorbance measurement value of the latex agglutination reaction is sent to the control unit and converted into the measurement value of the fecal occult blood marker. The measured value of the fecal occult blood marker is subjected to necessary processing such as printing on a printer and displaying on a display device (step S8: calculating hemoglobin concentration). This completes the measurement of one sample (step S9: data acquisition when hemoglobin is detected, alarm printing, etc.), and the measurement of the next sample is performed.

The fecal occult blood marker measured by the fecal occult blood measuring unit is not limited to one type, and a plurality of markers can be measured. For example, after measuring hemoglobin, it is also possible to measure calprotectin by newly collecting a stool suspension from the same stool collection container. Furthermore, as for tumor markers that can be detected in feces, those that can be measured by the latex agglutination immunoturbidimetry method can be combined as measurement items.

When the fecal occult blood test performed after the stool test confirmation determination is also performed by the absorbance measurement, the measurement wavelength may overlap with the measurement wavelength in the stool test confirmation determination.

The stool collection confirmation unit and the sample inspection unit can also have the following configurations.
(1) A stool collection confirmation unit and a sample inspection unit are provided independently, and samples are supplied to each to perform measurement. This configuration is suitable when the stool sample test is performed by a method other than absorbance measurement. In addition, when confirming stool collection, it is possible to add a substance to be detected in the stool sample test and a reagent that affects the reaction.
(2) The stool collection confirmation unit and the sample inspection unit are integrated, and the sample used for stool collection confirmation is used as it is for the stool sample inspection. This configuration is preferable when confirming stool collection by measuring the absorbance. When adding a reagent to the stool collection confirmation judgment, it is necessary to be careful not to affect the substance to be measured or the reaction in the subsequent stool sample test. Further, in the absorbance measurement, the flow path leading to the sample inspection section can be measured as a flow cell, and the measurement container (cell) for confirming stool collection can also be used as a reaction / measurement container for later stool sample inspection. You can also. With this configuration, the amount of sample required for determination and inspection of stool collection confirmation can be reduced.

In the above method, it is explained that the next stool sample is inspected even if it is determined that the stool has not been collected. However, if it is determined that the stool has not been collected, the stool sample may not be inspected. .. Further, the confirmation of stool collection may be determined after the stool sample is inspected.

(Control unit)
As described with reference to FIG. 2, the control unit 1-2 includes a calculation unit, a storage unit, and the like, an input unit that captures the absorbance measurement value, an input device 1-1 such as a keyboard and a touch panel, and a display and a printer. Output devices 1-3 such as are connected. Various communication ports such as RS-232C, LAN, and USB may be provided for performing data processing with an external device and monitoring the operating status of remote maintenance and inspection devices. The control unit 1-2 can be incorporated in the stool sample testing device of the present invention, or can be independently provided outside the stool sample testing device. In the latter case, an operation mode in which one control unit controls a plurality of stool sample testing devices is also possible.

The control unit 1-2 determines the confirmation of stool test based on the absorbance measurement value of the first wavelength, calculates the concentration of the fecal occult blood marker based on the absorbance measurement of the second wavelength, and operates the entire inspection device. It is also possible to control and handle various errors.

According to the present invention, even if the occult blood or tumor marker in the stool sample is negative in the stool sample testing device, retesting can be promoted by referring to the information of uncollected stool, and eventually colorectal cancer and the like. It is possible to prevent oversight of gastrointestinal diseases.

A Stool collection confirmation system 1-1 Input device 1-2 Control unit 1-3 Output device 1-4 Sample inhalation unit 1-5 Stool collection confirmation unit (absorbance measurement unit)
1-6 Fecal occult blood test department (absorbance measurement department)
3 Container body 5 Container lid 7 Sampling rod 15 Stool suspension 21 Stool collecting container 22 Sample cup 23 Filter 26 Pressing 24 Sample nozzle 25 Gripping All publications, patents and grips cited herein The patent application shall be incorporated herein by reference as is.

Claims (19)

It is equipped with a sample inhalation unit, a stool collection confirmation unit that detects uncollected stool samples based on the absorbance of the sample measured at the first wavelength, and a sample inspection unit.
A stool sample testing device that includes a stool suspension solution containing a buffer solution and may further contain a stool sample. The uncollected stool sample is a sample showing an absorbance below a preset threshold value.
The stool sample testing device according to claim 1, wherein the threshold value is determined based on the absorbance of the stool suspension solution. The stool sample inspection device according to claim 1 or 2, wherein the sample inspection unit has an absorbance measuring unit having a second wavelength. The stool sample inspection apparatus according to any one of claims 1 to 3, wherein the first wavelength is in the range of 300 nm to 510 nm. The stool sample inspection apparatus according to any one of claims 1 to 3, wherein the first wavelength is in the range of 300 nm to 450 nm. Any one of claims 1 to 3, wherein the first wavelength is any one of 295 nm to 305 nm, 335 nm to 345 nm, 375 nm to 385 nm, 400 nm to 415 nm, 445 nm to 455 nm, and 480 nm to 505 nm. The stool sample inspection device according to item 1. The stool sample inspection device according to any one of claims 1 to 6, wherein the inspection unit for the sample is an examination unit for carrying out an immunological measurement method. The stool sample testing apparatus according to claim 7, wherein the immunological measurement method is performed by an agglutination measurement method using insoluble carrier particles. The stool test device according to any one of claims 1 to 8, wherein the test unit of the sample detects a fecal occult blood marker and / or a tumor marker in a stool suspension. The stool sample inspection apparatus according to claim 3 , wherein the stool collection confirmation unit that measures the absorbance at the first wavelength also serves as the absorbance measurement unit at the second wavelength. It is a stool sample test method
The process of measuring the absorbance of the sample at the first wavelength,
A stool collection confirmation step for detecting an uncollected stool sample based on the measured absorbance, and a stool collection confirmation step.
It has a sample inspection process to measure the components in the sample.
A method for inspecting a stool sample, wherein the sample contains a solution for suspending stool containing a buffer solution and may further contain a stool sample. The uncollected stool sample is a sample showing an absorbance below a preset threshold value.
The stool sample test method according to claim 11, wherein the threshold value is determined based on the absorbance of the stool suspension solution. The stool sample inspection method according to claim 11 or 12, wherein the first wavelength is in the range of 300 nm to 510 nm. The stool sample inspection method according to claim 11 or 12, wherein the first wavelength is in the range of 300 nm to 450 nm. The first wavelength is any one of 295 nm to 305 nm, 335 nm to 345 nm, 375 nm to 385 nm, 400 nm to 415 nm, 445 nm to 455 nm, and 480 nm to 505 nm. Stool sample test method. The stool sample inspection method according to any one of claims 11 to 15, wherein the sample inspection step is an absorbance measurement at a second wavelength different from the first wavelength. The stool sample test method according to any one of claims 11 to 16, wherein the test of the sample is carried out by an immunological measurement method. The stool sample test method according to claim 17, wherein the immunological measurement method is performed by an agglutination measurement method using insoluble carrier particles. The stool test method according to any one of claims 11 to 18, wherein the sample inspection step detects a fecal occult blood marker and / or a tumor marker in the sample.

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